Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma

NCT ID: NCT05119413

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-12-15

Brief Summary

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Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.

Detailed Description

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Conditions

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Melanosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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New traitement

Thiamidol, retinoid, topical steroid preparation

Group Type EXPERIMENTAL

New trio de Kligman

Intervention Type DRUG

Once daily application in addition to the same sunscreen

Kligman's trio

Application once a day for 12 weeks

Group Type OTHER

Trio Kligman

Intervention Type DRUG

Once daily application in addition to the same sunscreen

Interventions

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New trio de Kligman

Once daily application in addition to the same sunscreen

Intervention Type DRUG

Trio Kligman

Once daily application in addition to the same sunscreen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

Exclusion Criteria

1. Pregnant woman
2. Other pigmentary disorder affecting the face
3. Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Passeron, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice, Service de Dermatologie

Locations

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CHU de Nice

Nice, Alpes-maritimes, France

Site Status

Countries

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France

Other Identifiers

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20-PP-30

Identifier Type: -

Identifier Source: org_study_id

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